Closure device for percutaneous occlusion of puncture sites and tracts in the human body and method

Abstract

A closure device for percutaneously forming a closure of a puncture in the tissue of human body. The device comprises a flexible elongate tubular member having proximal and distal extremities and a longitudinal axis. The flexible elongate tubular member has a first lumen extending from the proximal extremity to the distal extremity. A closure assembly is carried by the distal extremity of the flexible elongate tubular member and is movable between contracted and expanded positions. The closure assembly includes a closure mechanism covered by an impermeable membrane. A handle is carried by the proximal extremity of the flexible elongate tubular member and is adapted to be grasped by the human hand. A deployment mechanism is carried by the handle and extends through the flexible elongate tubular member and is coupled to the closure assembly for moving the closure assembly from the contracted position to the expanded position.

What is claimed: 
     
       1. A device for percutaneously forming a closure of a puncture in the tissue of the human body comprising a flexible elongate tubular member having proximal and distal extremities and extending along a longitudinal axis, the flexible elongate tubular member having a first lumen extending from the proximal extremity to the distal extremity, a closure assembly carried by the distal extremity of the flexible elongate tubular member, the closure assembly including a closure member movable between contracted and expanded positions, a deformable membrane substantially covering the closure member and secured to the distal extremity of the flexible elongate tubular member, a handle carried by the proximal extremity of the flexible elongate tubular member and adapted to be grasped by the human hand and deployment means carried by the handle and including a push-pull element having proximal and distal extremities, said deployment means extending through the flexible elongate tubular member and being coupled to the closure member for moving the closure member between the contracted position permitting introduction into a puncture and the expanded position permitting substantial occlusion of the puncture, and thereafter to the contracted position permitting removal from the puncture. 
     
     
       2. A closure device as in claim 1 wherein the membrane has a closed end and an open end circumscribed by a rim and means for securing the rim to the distal extremity of the flexible elongate tubular member, said membrane being formed to permit movement of the closure member within the membrane during movement between contracted and expanded positions to cause said membrane when the closure assembly is in an expanded position to assume a generally planar configuration lying in a plane which is generally perpendicular to the longitudinal axis of the flexible elongate tubular member with the membrane being disposed on opposite sides of the closure member and lying in generally parallel planes. 
     
     
       3. A closure device as in claim 1 wherein said membrane has a sock-like conformation in at least one position. 
     
     
       4. A closure device as in claim 1 wherein said closure member in an expanded or deployed position is sufficiently rigid so as to provide a supporting framework for the membrane. 
     
     
       5. A closure device as in claim 1 wherein said closure member is formed of a superelastic alloy material which when free has a substantial portion thereof which assumes a generally planar configuration. 
     
     
       6. A closure device as in claim 1 wherein said closure member is formed of a shape memory alloy material which when free has a substantial portion thereof which assumes a generally planar configuration. 
     
     
       7. A closure device as in claim 1 wherein said closure member when free assumes substantially a complex geometrical configuration. 
     
     
       8. A closure device as in claim 7, wherein said closure member when free assumes substantially a coil-like configuration. 
     
     
       9. A device for percutaneously forming a closure of a puncture site in the human body comprising a flexible elongate tubular member having proximal and distal extremities, a closure member carried by the distal extremity of the flexible elongate tubular member and being movable between contracted and expanded positions, said closure member in a contracted position having a diameter of up to 2.0 mm and in an expanded position having a diameter at least 3 mm, a deformable membrane at least partially covering the closure member and carried by the distal extremity of the flexible elongate tubular member and deployment means carried by the proximal extremity of the flexible elongate tubular member and coupled to the closure member for moving the closure member between the contracted position and the expanded position for substantially occluding the puncture. 
     
     
       10. A device for percutaneously forming a closure of a puncture in the tissue of the human body comprising a flexible elongate tubular member having proximal and distal extremities and extending along a longitudinal axis, the flexible elongate tubular member carrying a first lumen extending from the proximal extremity to the distal extremity, a closure assembly carried by the distal extremity of the flexible elongate tubular member and being movable between contracted and expanded positions, the closure assembly including a closure mechanism, an impermeable membrane at least partially covering the closure mechanism and being carried by the distal extremity of the flexible elongate tubular member, a handle carried by the proximal extremity of the flexible elongate tubular member and adapted to be grasped by the human hand and deployment means carried by the handle and including a push-pull wire having proximal and distal extremities, said deployment means extending through the flexible elongate tubular member and being coupled to the closure mechanism for moving the closure assembly from the contracted position able to be introduced into and through a puncture to the expanded position for substantially occluding the puncture, said closure mechanism when free assuming substantially a flower-like, complex geometrical configuration. 
     
     
       11. A device for percutaneously forming a closure of a puncture in the tissue of the human body comprising a flexible elongate tubular member having proximal and distal extremities and extending along a longitudinal axis, the flexible elongate tubular member carrying a first lumen extending from the proximal extremity to the distal extremity, a closure assembly carried by the distal extremity of the flexible elongate tubular member and being movable between contracted and expanded positions, the closure assembly including a closure mechanism, an impermeable membrane at least partially covering the closure mechanism and being carried by the distal extremity of the flexible elongate tubular member, a handle carried by the proximal extremity of the flexible elongate tubular member and adapted to be grasped by the human hand and deployment means carried by the handle and including a push-pull wire having proximal and distal extremities, said deployment means extending through the flexible elongate tubular member and being coupled to the closure mechanism for moving the closure assembly from the contracted position able to be introduced into and through a puncture to the expanded position for substantially occluding the puncture, said closure mechanism including a plurality of arms which when the closure assembly is in a contracted position lie in a generally cylindrical configuration which is in alignment with the longitudinal axis of the flexible elongate tubular member and in an expanded position extend radially from the longitudinal axis at substantially right angles thereto. 
     
     
       12. A closure device as in claim 11 wherein said closure mechanism comprises at least three radially extending arms. 
     
     
       13. A closure device as in claim 11 wherein said arms have proximal and distal ends with the proximal ends being secured to the distal extremity of the flexible elongate tubular member and means bonding together the distal ends of the arms and the distal end of the push-pull wire. 
     
     
       14. A closure device as in claim 11 wherein said arms are formed with hinge points permitting folding of the same during movement of the closure assembly from a contracted position to an expanded position. 
     
     
       15. A closure device as in claim 14 wherein said hinge points are provided in regions intermediate the proximal and distal ends of the arms and wherein portions of the arms disposed on opposite sides of the hinge points overlap each other when the arms are folded. 
     
     
       16. A closure device as in claim 14 wherein the distal extremity of the flexible elongate tubular member is provided with longitudinally extending circumferentially spaced apart slits to form arcuate segments and wherein said arcuate segments form at least a portion of said radially extending arms. 
     
     
       17. A device for percutaneously forming a closure of a puncture in the tissue of the human body comprising a flexible elongate tubular member having proximal and distal extremities and extending along a longitudinal axis, the flexible elongate tubular member carrying a first lumen extending from the proximal extremity to the distal extremity, a closure assembly carried by the distal extremity of the flexible elongate tubular and being movable between contracted and expanded positions, the closure assembly including a closure mechanism, an impermeable membrane at least partially covering the closure mechanism and being carried by the distal extremity of the flexible elongate tubular member, a handle carried by the proximal extremity of the flexible elongate tubular member and adapted to be grasped by the human hand and deployment means carried by the handle and including a push-pull wire having proximal and distal extremities, said deployment means extending through the flexible elongate tubular member and being coupled to the closure mechanism for moving the closure assembly from the contracted position able to be introduced into and through the puncture to the expanded position for substantially occluding the puncture, said closure mechanism including a plurality of circumferentially spaced apart arms having proximal and distal ends, said push-pull wire having a bore extending therethrough, and further including a pull wire slidably disposed in the bore in the push-pull wire and having proximal and distal extremities, means securing the proximal ends of the arms to the distal extremity of the push-pull wire, means securing the distal ends of the arms to the distal extremity of the pull wire, said deployment means including first means carried by the handle for causing movement of said push-pull wire along the longitudinal axis and second means carried by the handle for causing movement of the pull wire along the longitudinal axis independent of the longitudinal movement of the push-pull wire. 
     
     
       18. A device for percutaneously forming a closure of a puncture in the tissue of the human body comprising a flexible elongate tubular member having proximal and distal extremities and extending along a longitudinal axis, the flexible elongate tubular member carrying a first lumen extending from the proximal extremity to the distal extremity, a closure assembly carried by the distal extremity of the flexible elongate tubular and being movable between contracted and expanded positions, the closure assembly including a closure mechanism, an impermeable membrane at least partially covering the closure mechanism and being carried by the distal extremity of the flexible elongate tubular member, a handle carried by the proximal extremity of the flexible elongate tubular member and adapted to be grasped by the human hand, deployment means carried by the handle and including a push-pull wire having proximal and distal extremities, said deployment means extending through the flexible elongate tubular member and being coupled to the closure mechanism for moving the closure assembly from the contracted position able to be introduced into and through a puncture to the expanded position for substantially occluding the puncture and means carried by said flexible elongate tubular member for introducing a biological sealant into the puncture proximal to said closure mechanism, said means including a second lumen extending from the proximal extremity to the distal extremity of said flexible elongate tubular member, said second lumen terminating in an external port positioned adjacent said closure mechanism. 
     
     
       19. A closure device as in claim 18 wherein said means for introducing a biological sealant includes a wye adapter and first and second syringes carried by the wye adapter for carrying and introducing two separate components of a biological sealant into the second lumen. 
     
     
       20. A closure device as in claim 18 wherein said biological sealant is selected from a group consisting of: (a) fibrin glue; (b) collagen; (c) Avitene; (d) cellulose; (e) gelatin; (f) Gelfoam.   
     
     
       21. A device for percutaneously forming a closure of a puncture in the tissue of the human body comprising a flexible elongate tubular member having proximal and distal extremities and extending along a longitudinal axis, the flexible elongate tubular member carrying a first lumen extending from the proximal extremity to the distal extremity, a closure assembly carried by the distal extremity of the flexible elongate tubular member and being movable between contracted and expanded positions, the closure assembly including a closure mechanism, an impermeable membrane at least partially covering the closure mechanism and being carried by the distal extremity of the flexible elongate tubular member, a handle carried by the proximal extremity of the flexible elongate tubular member and adapted to be grasped by the human hand and deployment means carried by the handle and including a push-pull wire having proximal and distal extremities, said deployment means extending through the flexible elongate tubular member and being coupled to the closure member for moving the closure assembly from the contracted position able to be introduced into and through a puncture to the expanded position for substantially occluding the puncture, said closure assembly in a de-deployed configuration having a diameter ranging from 1.0 mm to 2.0 mm and said closure assembly in a deployed configuration having a diameter ranging from 3 to 7 mm, said closure assembly in a deployed configuration having a thickness of approximately 0.05 to 1 mm. 
     
     
       22. A method for percutaneously forming a closure of a puncture in tissue in the human body, the puncture having proximal and distal ends, by use of a closure device having a flexible elongate tubular member having proximal and distal extremities and a longitudinal axis and a first lumen extending from the proximal extremity to the distal extremity, a closure assembly carried by the distal extremity of the flexible elongate tubular member movable between contracted and expanded positions, said closure assembly including a closure mechanism and a flexible impermeable membrane covering the closure mechanism and being carried by the distal extremity of the flexible elongate tubular member, a handle carried by the proximal extremity of the flexible elongate member and deployment means carried by the handle and including a push-pull wire extending through the first lumen of the flexible elongate member and coupled to the closure mechanism for moving the closure assembly between expanded and contracted positions and in an expanded position providing a closure assembly which lies substantially in a plane generally perpendicular to the longitudinal axis of the flexible elongate member, the method comprising introducing the distal extremity of the flexible elongate tubular member and the closure assembly carried thereby through the puncture so that the closure assembly is disposed distally of the puncture, moving the closure assembly from a contracted position to an expanded position so that it lies substantially in a plane and pulling the flexible elongate tubular member proximally to bring the closure assembly into contact with the distal end of the puncture to seal the puncture and introducing a biological sealant to cause the biological sealant to surround the distal extremity of the flexible elongate member and to fill the puncture, permitting the biological sealant to cure for a predetermined amount of time, thereafter moving the closure assembly from the expanded position to a contracted position and removing the closure device from the biological sealant and permitting the biological sealant to close off any remaining hole to form closure of the puncture. 
     
     
       23. A method as in claim 22 together with the step of waiting a period of time ranging from one to fifteen minutes and then moving the closure assembly from the expanded position to the contracted position. 
     
     
       24. A method as in claim 23 wherein tissue in the human body includes a vessel having a wall with a blood carrying lumen therein and in which the puncture extends through the wall of the vessel and wherein the closure assembly is introduced into the lumen through the puncture and is moved from a contracted to an expanded position within the lumen and is brought into engagement with the wall of the vessel to form a seal between the wall of the vessel and the puncture. 
     
     
       25. A device for expansion within a blood vessel defined by a wall having a puncture therein comprising an elongate tubular member having proximal and distal extremities and having a longitudinal axis, the distal extremity being sized so that it is adapted to extend through the puncture in the wall, an expansion assembly carried by the distal extremity and movable between contracted and expanded positions, the expansion assembly including an expansile member movable between contracted and expanded positions and a deformable membrane covering the expansile member, said deformable membrane being sized so as to be capable of expanding as the expansile member moves from the contracted position to the expanded position and overlying and underlying the expansile member and deployment means carried by the proximal extremity of the elongate tubular member and adapted to be operated by the human hand for controlling movement of the expansile member between the contracted and expanded positions. 
     
     
       26. A device as in claim 25 wherein said expansile member is comprised essentially of a superelastic material. 
     
     
       27. A device as in claim 26 wherein said expansile member has a configuration in the free state that is substantially a coil shape. 
     
     
       28. A device as in claim 25 wherein said membrane is secured to distal extremity of the elongate tubular member. 
     
     
       29. A device as in claim 25 wherein said membrane is free to stretch relative to the expansile member. 
     
     
       30. A device as in claim 25 wherein said membrane has a closed end and an open end circumscribed by a rim, said membrane being disposed on opposite sides of the expansile member in the expanded position. 
     
     
       31. A device as in claim 25 wherein said membrane prior to expansion has a sock-like conformation. 
     
     
       32. A device as in claim 25 wherein said elongate tubular member is flexible. 
     
     
       33. A device as in claim 25 wherein said elongate tubular member has a lumen extending from the proximal to the distal extremity. 
     
     
       34. A device as in claim 30 wherein said closed end is free to move relative to said rim. 
     
     
       35. A percutaneous closure device for sealing a puncture in a wall defining a blood vessel having a lumen through which blood flows comprising an elongate tubular member having proximal and distal extremities and a longitudinal axis, an expansile assembly carried by the distal extremity of the tubular member, said expansile assembly including an expansile member and an expansile membrane extending over the expansile member, said expansile assembly being movable between contracted and expanded positions, said expanded assembly when in the contracted position being sized so that it is adapted to be moved through the puncture and into the lumen, and operator means carried by the tubular member accessible from the proximal extremity of the tubular member for causing movement of the expansile assembly from the contracted to the expanded position after the expansile assembly has been introduced into the lumen of the blood vessel to engage the wall of the vessel to form a closure for the puncture. 
     
     
       36. A device as in claim 35 wherein said expansile member is formed of a superelastic material having a shape memory at body temperature corresponding generally to the expanded position. 
     
     
       37. A device as in claim 36 wherein the expansile membrane in the expanded position of the expansile assembly lies in a plane. 
     
     
       38. A device as in claim 37 wherein the expansile membrane overlies and underlies the plane of the expansile member when the expansile assembly is in the expanded position. 
     
     
       39. A device as in claim 37 wherein the expansile membrane is sized so that it is made taut by the expansile member when the expansile assembly is in the expanded position. 
     
     
       40. A device as in claim 39 wherein the expansile membrane in the contracted position is in the form of a sock having an open end secured to the distal extremity of the elongate tubular member and enclosing the expansile member. 
     
     
       41. A method for percutaneously forming a closure of a puncture in tissue in the human body, the puncture having proximal and distal ends, by use of a closure device having a elongate tubular member having proximal and distal extremities and a longitudinal, a closure assembly carried by the distal extremity of the elongate tubular member movable between contracted and expanded positions, said closure assembly including a closure mechanism and a deformable membrane covering the closure mechanism and carried by the distal extremity of the elongate tubular member and deployment means carried by the proximal extremity of the elongate tubular member and adapted to be operated by the human hand, said deployment means being coupled to the closure assembly for moving the closure assembly between expanded and contracted positions, the method comprising introducing the distal extremity of the elongate tubular member and the closure assembly carried thereby through the puncture so that the closure assembly is disposed distally of the puncture, moving the closure assembly from a contracted position to an expanded position so that it lies substantially in a plane and pulling the elongate tubular member proximally to bring the closure assembly into contact with the distal end of the puncture to seal the puncture and, after a predetermined period of time, moving the closure assembly from the expanded position to a contracted position and removing the closure device from the remaining hole to form closure of the puncture. 
     
     
       42. A method for expanding a device within a blood vessel having a lumen defined by a wall having a puncture therein by use of a device comprising an elongate tubular member having proximal and distal extremities and having a longitudinal axis, the distal extremity being sized so that it is adapted to extend through the puncture in the wall, an expansion assembly carried by the distal extremity and movable between contracted and expanded positions, the expansion assembly including an expansile member movable between contracted and expanded positions and a deformable membrane covering the expansile member, said deformable membrane being sized so as to be capable of expanding as the expansile member moves from the contracted position to the expanded position and overlying and underlying the expansile member and deployment means carried by the proximal extremity of the elongate tubular member and adapted to be operated by the human hand for controlling movement of the expansile member between the contracted and expanded positions, the method comprising introducing the distal extremity of the elongate tubular member and the expansion assembly carried thereby through the puncture so that the expansion assembly is disposed distally of the puncture, moving the expansion assembly from a contracted position to an expanded position and pulling the elongate tubular member proximally to bring the expansion assembly into contact with the wall of the blood vessel to seal the puncture and, after a predetermined period of time, moving the expansion assembly from the expanded position to a contracted position and removing the expansion device from the remaining hole to form closure of the puncture.